GxP Lifeline

Now that you understand what the Medical Device Single Audit Program (MDSAP) is and how it can benefit your medtech company, learn more about MDSAP’s audit process and how to successfully steer your company through the specifics of the journey. This is Part 2 of a three-part blog series about MDSAP.

Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

A mock U.S. Food and Drug Administration (FDA) audit can be conducted by an internal team of employees qualified by experience in regulatory compliance or by an external team with previous FDA work experience. Incorporating routine mock FDA audits can help your organization prepare for a FDA audit as well as reduce the number of audit observations and repeat observations received from regulatory authorities.

Conducting supplier audits is a well-established way to identify, eliminate and prevent quality problems in a supplier’s products, processes or management system before the problems spread. Still, there are ways to improve supplier audits. In a recent article for Pharmaceutical Manufacturing, MasterControl Senior Product Manager Terrance Holbrook recommended five actions take to to better conduct onsite supplier audits.

You use computers on a daily basis, and you may even use the system that needs to be audited. But you don’t spend your day thinking about where all the system components are located, how services and software are combined, and what Part 11 requirements apply.

The next time you attend an industry function like BIO, BioEast, or an AABB conference, start up a conversation about FDA inspections with those seated at your luncheon table. It's more than likely that everybody will describe a different inspection experience and that no two perceptions will be the same.

The word "audit," in the broadest sense, refers to a variety of activities. It may refer to an accounting firm examining the financial statements of a public corporation, or a consultant checking the process of lid sealant dispensing in a semiconductor package assembly line. It may even refer to a mystery shopper testing the patience of sales clerks in an upscale department store.

Manufacturing organizations on a global scale have instituted ways of qualifying suppliers to ensure that their capabilities have been verified. The types of qualification methods used are multifold. Some include quality and business system components that are essential for effective production or service rendering. Others may simply focus on quality characteristics, and still others may only consider production and equipment capabilities. More effective methods, however, include a combination o

If you're familiar with 21 CFR Part 11 documentation, you're likely acquainted with compliance audits, electronic record integrity and approval processes. However, you may wonder what the term "readily available" means or what "instantly" refers to in the same context. According to Labcompliance News1, it's these phrases that keep regulated companies guessing.

Operating under the oversight of the FDA and other global regulatory agencies creates a climate of transparency for regulated companies; any misstep can result in severe consequences such as product seizures, recalls, or company closure. Therefore, the way you respond to FDA Form-483 observations, warning letters, and other critical events is vital to your company's survival. Having a sound quality management system in place is critical, but when remedial action is necessary, time is of the essence. After all, you have only 15 working days from the receipt of the 483 to respond!

Companies that choose to produce medical products come under the regulatory laws of the countries in which they market their products. For the U.S., this falls under the purview of the U.S. FDA, with its CGMPs, “Current [best practices] Good Manufacturing Practices”, as codified in 21 CFR 4, Combination Products, 21 CFR 111, Dietary Supplements, 21 CFR 211, Pharmaceuticals, and 21 CFR 820, Medical Devices, and others.

American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.

Medical device manufacturers rely on suppliers for many things. Choosing the right vendors and managing them effectively can increase a manufacturer’s efficiency—in terms of time, cost, and quality. Unfortunately, suppliers can also sometimes put their clients in hot water when their quality standards are below par.

By now, we all know that risk-based monitoring (RBM) isn’t just about changing the role of the clinical research associate (CRA); it’s transforming the way clinical studies are managed. So what does that mean for quality assurance (QA) teams who audit these new processes? Polaris president Celine Clive led a roundtable discussion about RBM and its implications for auditing at November’s North Carolina Regulatory Affairs Forum (NCRAF) meeting.

When we invest in tools, we naturally want the most bang for our buck. Who hasn’t tried to use a screwdriver as a pry bar or a pair of pliers for loosening a bolt when a properly sized wrench would be more appropriate?

A recent quality management system benchmark survey showed manual processes are still predominant over automated systems.[1] The results of the survey were compiled from over 100,000 professionals worldwide and the majority of the participants work in quality or regulatory positions across pharmaceutical, medical device and biotech industries.

Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

For the aerospace, defense, automotive, pharmaceutical or medical device industries, it really makes no difference when it comes to auditing the effectiveness of the quality management system (QMS): An established auditing program is a fundamental requirement. ISO 9001, ISO 13485, AS 9100, and the primary topic of most of Dr. D’s rants 21 CFR, Part 820 compliance, all have elements mandating that quality audits be performed. So the doctor always finds it quite disturbing when a device establishment fails to comprehend the importance of creating an audit schedule and actually performing the audits.